PROJECT SUMMARY The overall goal of this Phase I proposal is to design, develop and test the feasibility of advanced quantitative magnetic resonance imaging (MRI) phantoms that mimic the simultaneous presence of fat, iron and fibrosis. Fat, iron and fibrosis are three principal histological coexisting features of many important disease states. Phantoms are highly controlled test objects that accurately reflect tissue characteristics in both normal and pathological tissues. Emerging quantitative MRI methods introduced in the past ~5 years are increasingly used for non-invasive diagnosis, staging and treatment monitoring in both clinical care and clinical trials. However, the lack of viable MRI phantoms that mimic the combination of fat, iron and fibrosis experienced in disease states is a major barrier to the development of new quantitative MRI biomarkers, as well as effective quality assurance in clinical environments. Such phantoms are also needed for quality assurance, calibration and qualification of MRI scanners for use in multicenter drug development trials. In this proposal, we will develop and optimize novel quantitative MRI phantoms for the validation and quality assurance of MRI techniques to assess fat, iron and fibrosis in tissue. In this collaborative project between Calimetrix, LLC, and the University of Wisconsin-Madison, we will design, optimize and validate the formulation of the individual vials comprising the phantom (Aim 1), as well as the phantom housing (Aim 2), and we will validate the complete phantom using established techniques as well as novel rapid MRI methods used for multiple emerging quantitative applications (Aim 3). Successful design, development and validation of advanced phantoms that accurately reflect tissue characteristics are a critical step in the development and dissemination of quantitative imaging biomarkers, which will have major impact by reducing cost, improving safety, and improving the early diagnosis and intervention, affecting the health of millions of Americans.